MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C16000 SYSTEM; AUTOMATED CHEMISTRY ANALYZER

Catalog Number 03L77-01

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false elevated magnesium patient results generated using the architect c16000 analyzer.The following data was provided.The customer uses normal range 0.7 to 1.0 mmol/l.(b)(4) initial 3.9, repeat 0.65.No impact to patient management was reported.

Manufacturer Narrative

Investigation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling, and instrument service.No returns were made available from the customer site for this evaluation.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.The issue was resolved through standard troubleshooting procedures.Based on all available information and abbott diagnostics complaint investigation, the analyzer performed as intended and no product deficiency was identified.

Manufacturer Narrative

(b)(4).Submission 1628664-2016-00227 documents the incident and subsequent investigation summary for the architect c16000, list 03l77-01, serial (b)(4).After completion of our investigation it was determined the analyzer that generated the incorrect result was the architect c8000, list 01g06-01, serial (b)(4) and a new submission 1628664-2016-00284 was submitted for the architect c8000 due to our system requirements.Therefore, this second follow-up to 1628664-2016-00227 is being submitted referring to 1628664-2016-00284 and clarifying that mdr 1628664-2016-00285 follow-up was incorrectly submitted.Note: this follow up is in response to an fda inquiry regarding mdr 1628664-2016-00285, indicating a correction was needed and 1628664-2016-00285 would be deleted from the system.

• Brand Name: ARCHITECT C16000 SYSTEM
• Type of Device: AUTOMATED CHEMISTRY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 5930418
• MDR Text Key: 54028407
• Report Number: 1628664-2016-00227
• Device Sequence Number: 0
• Product Code: JGJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03L77-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/06/2016
• Initial Date FDA Received: 09/06/2016
• Supplement Dates Manufacturer Received: Not provided; 06/23/2020
• Supplement Dates FDA Received: 09/16/2016; 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLINICAL CHEMISTRY MAGNESIUM; LIST NUMBER 03P68-21; LOT NUMBER 91900UN15; CLINICAL CHEMISTRY MAGNESIUM; LIST NUMBER 03P68-21; LOT NUMBER 91900UN15